Trial Outcomes & Findings for Evaluation of Irritation That Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face. (NCT NCT00714714)

Results Overview

Cumulative daily weekday scores for two weeks on Expert Grader Assessments: Dryness (0-8, none-deep)and Erythema (0-8, none-severe) and Self-Assessments: Burning/Stinging (0-3, none-severe) and Itching (0-3, none-severe)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

cumulative daily weekday scores for two weeks

Results posted on

2012-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Combined Arms All subjects received treatment with both gels in a split-face model
Overall Study STARTED	25
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Combined Arms All subjects received treatment with both gels in a split-face model
Overall Study Adverse Event	1

Baseline Characteristics

Evaluation of Irritation That Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combined Arms n=25 Participants All subjects received treatment with both gels in a split-face model
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	30.36 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: cumulative daily weekday scores for two weeks

Population: One panelist terminated treatment on Day 2. Her scores were carried over and the analysis was based on Intention to Treat (ITT).

Cumulative daily weekday scores for two weeks on Expert Grader Assessments: Dryness (0-8, none-deep)and Erythema (0-8, none-severe) and Self-Assessments: Burning/Stinging (0-3, none-severe) and Itching (0-3, none-severe)

Outcome measures

Outcome measures
Measure	Adapalene n=25 Participants Adapalene facial gel was applied daily to one side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).	Tretinoin n=25 Participants Tretinoin facial gel was applied daily to the opposite side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
Assessment of Facial Irritation and Cutaneous Effects Erythema (cumulative scores on a scale)	4.8 Ordinal data treated as interval Standard Deviation 4.2	3.9 Ordinal data treated as interval Standard Deviation 5.4
Assessment of Facial Irritation and Cutaneous Effects Dryness (cumulative scores on a scale)	8.8 Ordinal data treated as interval Standard Deviation 6.2	6.7 Ordinal data treated as interval Standard Deviation 8.5
Assessment of Facial Irritation and Cutaneous Effects Burning/Stinging (cumulative scores on a scale)	2.0 Ordinal data treated as interval Standard Deviation 2.6	2.4 Ordinal data treated as interval Standard Deviation 5.9
Assessment of Facial Irritation and Cutaneous Effects Itching (cumulative scores on a scale)	1.4 Ordinal data treated as interval Standard Deviation 1.5	0.8 Ordinal data treated as interval Standard Deviation 1.0

Adverse Events

Adapalene

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tretinion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Lineberry, Associate Director Clinical Operations

Valeant Pharmaceuticals International, Inc

Phone: 949-973-1153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60